An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Type 2 Diabetes Mellitus Clinical Trial

— FINEROD  

Official title:

Finerenone Research of Outcomes and Drug Utilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278207
• Other study ID #: 22731
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study, in which data from people in Japan with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems. The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone. The data will come from a network of commercial electronic health records (EHRs) and national claims data in Japan. They cover the period from July 1st, 2021 until September 2023. Only already available data is collected and studied. There are no required visits or tests in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
• No recorded prescription for finerenone in the 12 months prior to the index date
• Age of 18 years or older as of the index date
• Evidence of T2D at any point before (and including) the index date.
• CKD stages 2-4 related to eligibility will be defined according to the presence of the

following criteria at any point before (and including) the index date:

• A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified
• two UACR tests results = 30 mg/g separated by at least 90 days and by not more than 540 days
• two different eGFR test results = 15 mL/min/1.73 m2 AND < 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days

Exclusion Criteria:

• Type 1 diabetes (T1D) defined as a recorded diagnosis for this disease in the patient medical record
• Kidney cancer
• Kidney failure defined as follows:
• Two different eGFR test results < 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
• Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
• A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Finerenone (BAY 94-8862)
10 mg or 20 mg daily

Locations

Country	Name	City	State
Germany	Bayer	Berlin
Japan	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.	Sociodemographic characteristics such as age, sex, race and socio-economic status.	12 months before first prescription/dispensation of finerenone (index date)
Primary	Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.	Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)	12 months before first prescription/dispensation of finerenone (index date)
Primary	Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.	In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage	12 months before first prescription/dispensation of finerenone (index date)
Secondary	Proportion of finerenone initiators with and without UACR measurements at baseline	UACR=Urinary Albumin-to-Creatinine Ratio	From first prescription/dispensation of finerenone (index date) until 12 months after index date
Secondary	Mean UACR in the subcohort with UACR measurements		From first prescription/dispensation of finerenone (index date) until 12 months after index date
Secondary	Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.	Any of the following: = 2 outpatient eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days; Record of dependence on dialysis (at least 3 sessions over at least 90 days); Diagnosis records of kidney failure or CKD stage 5; Record of kidney transplant	From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Secondary	Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.	Acute myocardial infarction, identified as an inpatient hospital diagnosis of fatal or non-fatal acute myocardial infarction. Congestive heart failure, identified as an impatient hospital or emergency department diagnosis of heart failure and stratified by new-onset or recurrent heart failure.	From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Secondary	Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.	Depending on the database used, this includes incidence of drug use, initiation of treatment measured by drug prescription, drug dispensation, or a combination of both depending on data availability, dosing regimen, treatment persistence and non-persistence, and implementation measured as the proportion of days covered.	From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Secondary	Number of participants who initiate finerenone at a 10 mg dose daily		At day 0 (first prescription/dispensation of finerenone)
Secondary	Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark		From first prescription/dispensation of finerenone (index date) until 12 months after index date
Secondary	Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark		From first prescription/dispensation of finerenone (index date) until 12 months after index date
Secondary	Number of participants who initiate finerenone at a 20 mg dose daily		At day 0 (first prescription/dispensation of finerenone)
Secondary	Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark		From first prescription/dispensation of finerenone (index date) until 12 months after index date
Secondary	Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark		From first prescription/dispensation of finerenone (index date) until 12 months after index date

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